


Seohyung Lee Chief Attorney
Chief Attorney
Conseiller auprès du Ministère de la Sécurité Alimentaire et Médicamentaire
Chief Attorney
Conseiller auprès du Ministère de la Sécurité Alimentaire et Médicamentaire
« Partenaire juridique du secteur de la santé avec une expertise en matière de réglementation et de gestion des risques »
Seohyung Lee, avocat au sein du groupe AI/Intelligence et du groupe Medical Bio Healthcare, fournit une analyse tridimensionnelle des problèmes de réglementation, de conformité et de litiges survenant dans divers secteurs et fournit des conseils stratégiques qui tiennent compte de l'intersection de la technologie et du droit. Il est un avocat spécialiste de la réglementation qui a présenté des solutions axées sur la pratique dans des domaines qui nécessitent à la fois l'utilisation des données et une réponse réglementaire, en particulier dans les secteurs de la santé, de la bio, de la santé numérique et de la haute technologie. Dans les industries technologiques telles que les produits pharmaceutiques, les dispositifs médicaux, les soins de santé numériques et les produits biopharmaceutiques avancés, nous avons analysé les risques réglementaires tout au long du processus, depuis la phase de recherche et développement jusqu'à l'autorisation, les essais cliniques, le marketing, la publicité et l'utilisation des données, et avons conçu un système de conformité adapté à la structure de l'IA et de l'utilisation des données. En plus d'être avocat, il possède les qualifications de pharmacien, de conseil en brevets et de docteur en droit. Il a également été chercheur principal à l'Institut de recherche en droit de l'Université nationale de Séoul et professeur-chercheur à l'Institut de recherche en droit biomédical de l'Université Ewha Womans, accumulant une pratique réglementaire et une expérience de conseil dans diverses institutions et sites industriels. Nous nous concentrons sur la fourniture d'interprétations pratiques et de systèmes de conseil orientés stratégie pour atteindre les objectifs commerciaux de nos clients dans l'environnement réglementaire.
Expérience
- (Former) Practical training at Yoon & Yang Law Firm, Inc.
- (Former) LK Partners Law Firm
- (Former) Senior Researcher, Law Research Institute, Seoul National University Law School
- (Former) Research Professor, Biomedical Law Research Institute, Ewha Womans University Law School
- (Former) Seung Law Firm
- (Current) Daeryun Law Firm (Limited)
Activités principales
- Advisor to the Ministry of Food and Drug Safety
- Member of the Ministry of Food and Drug Safety Administrative Disposition Review Committee
- Legislative Director, Academic Committee Member, Korean Medical Information Society
- Samsung Seoul Hospital Data Review Board (DRB) member
- Member of Institutional Bioethics Committee (IRB) at Seoul National University Bundang Hospital
- Hanyang University Guri Hospital Institutional Bioethics Committee (IRB) member, advisory member
- Advisory member of the Future Medical Research Foundation under the Ministry of Science and ICT
- Advisory member of the Korean Association of Medical Social Workers
- Legal advice to members of the Korean Neuropsychiatric Association
- Member of Korean Medical Law Society
- Member of the Korean Society of Bioethics
- Member of Korean Legal Philosophy Society
- Ministry of Health and Welfare, Ministry of Food and Drug Safety and affiliated public institutions, and related academic societies and associations invited to lecture at symposiums and academic conferences
- Contributions, books, and university lectures in the biomedical field
Réalisations principales
- Advice on research, development and marketing, including clinical trials (IRB and clinical trial plan approval, etc.) of drugs and medical devices, GMP, product approval, health insurance listing and drug price determination, adverse reaction reporting, labeling and advertising, etc.
- Advising on research and development of new medical technology products such as digital healthcare and advanced biopharmaceuticals, application for new medical technology evaluation, and marketing.
- Advised on practical work related to certification of innovative pharmaceutical companies and Ministry of Health and Welfare and Korea Health Industry Development Institute
- Litigation regarding administrative measures such as license suspension and business suspension of medical personnel and medical institutions
- Compliance advice on advertising regulations for medical institutions, pharmaceuticals, medical devices, etc.
- Litigation related to medical disputes between medical institutions and patients
- Compliance advisory and litigation related to rebates
- Advising on the establishment of medical corporations and overseas expansion of medical institutions
- Participating in revising laws on bioethics and safety, enacting the Advanced Regenerative Bio Act, and revising the “Health and Medical Data Utilization Guidelines”
- Legislative consulting on laws, notices, and guidelines such as the Pharmaceutical Affairs Act, Medical Services Act, Medical Device Act, Bioethics and Safety Act, Fair Trade Act, Advanced Regenerative Bio Act, Personal Information Protection Act, Cosmetics Act, and Food Sanitation Act.
- Advisory and litigation related to contracts with hospital management support companies (MSO)
- Evidence investigation and evidence preservation application case for compensation for urological medical accident damages
- Health Insurance Review and Assessment Service, lawsuit against Ministry of Health and Welfare's administrative disposition related to nursing care benefits
- Advice on data processing and privacy protection regulations
- Advised a large construction company on product liability.
- Advice on intellectual property rights, including technology licensing, patents, and trademark infringement
- Advisory and litigation regarding regulatory sandbox application by the Ministry of Science and ICT
Formation
- Graduated from Ewha Womans University College of Pharmacy, Department of Pharmaceutical Sciences (Bachelor of Pharmacy)
- Graduated from Ewha Womans University Law School (Master of Laws)
- Graduated from Ewha Womans University, Department of Law (Doctor of Laws)
Publications et articles
- 『Law and Life of Koreans (Completely Revised Edition)』 (Ministry of Justice/Korean Legal Education Center, 2021)
- 『Law and Philosophy in the Corona Era』 (Parkyoungsa, 2021)
- 『Biomedical Ethics (Completely Revised 4th Edition)』 (Dongnyok, 2023)
- 『Health and Medical Informatics』 (Gunja Publishing, 2024)
- 『Criminal) Correctional Precedents』 (Parkyoungsa, 2024)
- “Duty of outpatient prescription medical institutions to return pharmaceutical expenses in relation to the comprehensive fee system - Focusing on the Supreme Court decision 2009du8786 pronounced on November 26, 2009 - ”, 「Bioethics Policy Research」 Vol. 5, No. 1 (2011).
- “Contemplation of the construction of domestic health care big data legislation - Focusing on the guarantee of the right to know -”, 「Medical Jurisprudence」 Vol. 19, No. 3 (2018).
- “Study on measures to improve anonymization under bioethics law”, Bioethics Vol. 20, No. 2 (2019).
- “Review of personal information protection legislation and direction of revision from the perspective of privacy protection - Focusing on the dichotomy between public and private sectors -”, 「Bioethics Policy Research」 Vol. 13, No. 2 (2020), etc.
Certifications
- Attorney
- Pharmacist
- Patent Attorney
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